Machine Learning-based Longitudinal Study of Post-ICU Syndrome Development Trajectory in Critically Ill Patients and Construction of Clinical Early Warning Models: a Research Protocol for Longitudinal Study

This project intends to track and evaluate whether post-ICU syndrome will occur 7 days, 1 month, 3 months and 6 months after ICU patients are transferred out of the ICU through a longitudinal study, apply the latent category growth model to identify different trajectory patterns of post-ICU syndrome in critically ill patients, and use modern machine learning models to build an early warning model of the trajectory patterns of post-ICU syndrome.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorder; Cognitive Impairment; Memory Disorders; Intensive Care Unit Syndrome; Prediction

• Study Type: Observational
• Enrollment (Estimated): 840

Contacts and Locations

• Study Contact: Name: Tingrui WANG; Phone Number: 19117899885; Email: W19117899885@163.com

Study Locations

• China
  • Guizhou
    • GuiYang, Guizhou, China, 550004
      • Recruiting
      • Affiliated Hospital of Guizhou Medical University
      • Contact: Tingrui WANG; Phone Number: 19117899885; Email: W19117899885@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Stage one involved studying patients discharged from the ICU and their families to investigate the occurrence and factors influencing post-intensive care syndrome (PICS), identifying various developmental patterns of PICS. A minimum sample size of 840 patients and 420 family members was established. Stage two focused on developing and evaluating a machine learning-based early warning model for PICS. The model construction utilized data from stage one, while the evaluation included 525 patients and 393 family members who met the exclusion criteria.

Description

Inclusion Criteria patients :

• Length of stay in ICU ≥24h;
• Age ≥18 years old;
• Conscious when leaving ICU, communicating with investigators without barriers;
• Informed consent. Family members：
• One family member ≥18 years of age was selected for each patient;
• Assume the main role of caring for patients and medical decision-making;
• No history of mental illness or other serious organic diseases;
• Informed consent and voluntary participation in this study.

Exclusion Criteria patients :

• Have been in ICU for more than 24h within 3 months before this admission;
• Transferred to another ICU;
• Cognitive impairment existed before ICU admission (BDRS > 4 points);
• Severe hearing impairment, dysarthria, etc., which cannot be followed up;
• Unable to complete the questionnaire survey due to serious illness.

Family members:

• Family members refuse to participate in the study due to their own reasons;
• Severe hearing and language impairment, unable to cooperate with researchers.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation scale score	Patient: Post-icu syndrome assessment of ICU survivors: Healthy Aging Brain Care monitoring(HABC Monitor) score;; ICU related Memory: Intensive Care Unit Memory Tool (ICUMT);; Sleep quality: Richards-Campbell Sleep Questionnaire (RCSQ);; Perceived Social Support Scale (PSSS). Family members: Sleep quality of family members: Richards-Campbell Sleep Questionnaire (RCSQ);; anxiety and Depression of family members: Hospital anxiety and Depression Scale score;; Family fatigue: Scores of fatigue rating Scale;; PTSD of family members: Event Impact Scale score;	2024-2026

Collaborators and Investigators

• Sponsor: The Affiliated Hospital Of Guizhou Medical University
• Collaborators: Chinese nursing association
• Investigators: Study Chair: Li Yao, Affiliated Hospital of Guizhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 19, 2024
• First Submitted That Met QC Criteria: May 19, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Prediction model; Post-icu syndrome; Development Trajectory
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Pathologic Processes; Disease; Neurobehavioral Manifestations; Syndrome; Sleep Wake Disorders; Memory Disorders
• Other Study ID Numbers: ZHKYQ202316; No. ZHKYQ202316 (Other Grant/Funding Number: Chinese Nursing Association); No. Gyfynsfc[2023]35 (Other Grant/Funding Number: The Affiliated Hospital of Guizhou Medical University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No